Multi-event April 2022 FDA Recall Depo-medrol by Mckesson Medical-surgical Inc. Corporate Office

This Multi-event Class II drug recall was voluntarily initiated by Mckesson Medical-surgical Inc. Corporate Office on April 13, 2022 for the product Depo-medrol. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1012-2022 TERMINATED D-1011-2022 TERMINATED D-0993-2022 TERMINATED D-1032-2022 TERMINATED D-1075-2022 TERMINATED D-1055-2022 TERMINATED D-1117-2022 TERMINATED D-1021-2022 TERMINATED D-1009-2022 TERMINATED D-1022-2022 TERMINATED D-1046-2022 TERMINATED D-1025-2022 TERMINATED D-1054-2022 TERMINATED D-1103-2022 TERMINATED D-1111-2022 TERMINATED D-0995-2022 TERMINATED D-1104-2022 TERMINATED D-1082-2022 TERMINATED D-1037-2022 TERMINATED D-1088-2022 TERMINATED D-1102-2022 TERMINATED D-1059-2022 TERMINATED D-1095-2022 TERMINATED D-1020-2022 TERMINATED D-1068-2022 TERMINATED D-1024-2022 TERMINATED D-1097-2022 TERMINATED D-1094-2022 TERMINATED D-1112-2022 TERMINATED D-1085-2022 TERMINATED D-1096-2022 TERMINATED D-1106-2022 TERMINATED D-1019-2022 TERMINATED D-1045-2022 TERMINATED D-1052-2022 TERMINATED D-1028-2022 TERMINATED D-1047-2022 TERMINATED D-1049-2022 TERMINATED D-1065-2022 TERMINATED D-1053-2022 TERMINATED D-1084-2022 TERMINATED D-1031-2022 TERMINATED D-1018-2022 TERMINATED D-1057-2022 TERMINATED D-1092-2022 TERMINATED D-1109-2022 TERMINATED D-1063-2022 TERMINATED D-1080-2022 TERMINATED D-1122-2022 TERMINATED D-1007-2022 TERMINATED D-1036-2022 TERMINATED D-1016-2022 TERMINATED D-1091-2022 TERMINATED D-1119-2022 TERMINATED D-1001-2022 TERMINATED D-1029-2022 TERMINATED D-0996-2022 TERMINATED D-1121-2022 TERMINATED D-1077-2022 TERMINATED D-1098-2022 TERMINATED D-1110-2022 TERMINATED D-0994-2022 TERMINATED D-1010-2022 TERMINATED D-1099-2022 TERMINATED D-1061-2022 TERMINATED D-1015-2022 TERMINATED D-1078-2022 TERMINATED D-1108-2022 TERMINATED D-1072-2022 TERMINATED D-1030-2022 TERMINATED D-1120-2022 TERMINATED D-1003-2022 TERMINATED D-1070-2022 TERMINATED D-1069-2022 TERMINATED D-1000-2022 TERMINATED D-1006-2022 TERMINATED D-1002-2022 TERMINATED D-1058-2022 TERMINATED D-1113-2022 TERMINATED D-1034-2022 TERMINATED D-1100-2022 TERMINATED D-1079-2022 TERMINATED D-1067-2022 TERMINATED D-1005-2022 TERMINATED D-1004-2022 TERMINATED D-1066-2022 TERMINATED D-1087-2022 TERMINATED D-1090-2022 TERMINATED D-1064-2022 TERMINATED D-1089-2022 TERMINATED D-0997-2022 TERMINATED D-1023-2022 TERMINATED D-1073-2022 TERMINATED D-1050-2022 TERMINATED D-1074-2022 TERMINATED D-1086-2022 TERMINATED D-0999-2022 TERMINATED D-1062-2022 TERMINATED D-1033-2022 TERMINATED D-1107-2022 TERMINATED D-1044-2022 TERMINATED D-1101-2022 TERMINATED D-1056-2022 TERMINATED D-1008-2022 TERMINATED D-1071-2022 TERMINATED D-1035-2022 TERMINATED D-1060-2022 TERMINATED D-1039-2022 TERMINATED D-1017-2022 TERMINATED D-1081-2022 TERMINATED D-1076-2022 TERMINATED D-1038-2022 TERMINATED D-1105-2022 TERMINATED D-1043-2022 TERMINATED D-1093-2022 TERMINATED D-1114-2022 TERMINATED D-1013-2022 TERMINATED D-1027-2022 TERMINATED D-1116-2022 TERMINATED D-1041-2022 TERMINATED D-1118-2022 TERMINATED D-0998-2022 TERMINATED D-1083-2022 TERMINATED D-1026-2022 TERMINATED D-1048-2022 TERMINATED D-1042-2022 TERMINATED D-1040-2022 TERMINATED D-1115-2022 TERMINATED D-1051-2022 TERMINATED D-1014-2022 TERMINATED

Recall Number: D-1012-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
4 cartons/2 auto injectors each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

49502-500-01 Epipen
49502-500-02 Epipen
49502-500-92 Epipen
49502-501-01 Epipen Jr
49502-501-02 Epipen Jr
49502-501-92 Epipen Jr

Recall Number: D-1011-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-0993-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.

Affected Packages Involved in this Recall

49502-500-01 Epipen
49502-500-02 Epipen
49502-500-92 Epipen
49502-501-01 Epipen Jr
49502-501-02 Epipen Jr
49502-501-92 Epipen Jr

Recall Number: D-1032-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

63304-614-20 Doxycycline
63304-614-05 Doxycycline
63304-614-01 Doxycycline
63304-614-13 Doxycycline
63304-615-05 Doxycycline
63304-615-11 Doxycycline
63304-615-01 Doxycycline
63304-616-20 Doxycycline
63304-616-05 Doxycycline
63304-616-01 Doxycycline
63304-616-13 Doxycycline
63304-616-50 Doxycycline

Recall Number: D-1075-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC 0093-1010-42, MFG: Teva Pharma USA

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0093-1010-42 Mupirocin

Recall Number: D-1055-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/100 blisters per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0904-5853-61 Ibuprofen
0904-5853-60 Ibuprofen
0904-5853-40 Ibuprofen
0904-5854-61 Ibuprofen
0904-5854-60 Ibuprofen
0904-5854-40 Ibuprofen
0904-5855-61 Ibuprofen
0904-5855-60 Ibuprofen
0904-5855-40 Ibuprofen

Recall Number: D-1117-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
26 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0264-3103-11 Cefazolin Sodium
0264-3105-11 Cefazolin Sodium
0264-3107-11 Cefazolin Sodium

Recall Number: D-1021-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
56 pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0487-0201-01 Ipratropium Bromide And Albuterol Sulfate
0487-0201-02 Ipratropium Bromide And Albuterol Sulfate
0487-0201-03 Ipratropium Bromide And Albuterol Sulfate
0487-0201-60 Ipratropium Bromide And Albuterol Sulfate

Recall Number: D-1009-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
10 cartons/10 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

55150-111-10 Ampicillin
55150-112-10 Ampicillin
55150-113-10 Ampicillin
55150-114-20 Ampicillin

Recall Number: D-1022-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
58 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

42023-159-01 Adrenalin
42023-159-25 Adrenalin
42023-168-01 Adrenalin

Recall Number: D-1046-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
30 bottles/100 capsules per bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0185-0674-10 Hydroxyzine Pamoate
0185-0674-05 Hydroxyzine Pamoate
0185-0674-01 Hydroxyzine Pamoate
0185-0615-10 Hydroxyzine Pamoate
0185-0615-05 Hydroxyzine Pamoate
0185-0615-01 Hydroxyzine Pamoate
0185-0613-10 Hydroxyzine Pamoate
0185-0613-05 Hydroxyzine Pamoate
0185-0613-01 Hydroxyzine Pamoate
0185-0676-10 Hydroxyzine Pamoate
0185-0676-05 Hydroxyzine Pamoate
0185-0676-01 Hydroxyzine Pamoate

Recall Number: D-1025-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
12 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0781-2020-31 Amoxicillin
0781-2020-76 Amoxicillin
0781-2020-01 Amoxicillin
0781-2020-05 Amoxicillin
0781-2613-31 Amoxicillin
0781-2613-76 Amoxicillin
0781-2613-01 Amoxicillin
0781-2613-05 Amoxicillin
0781-5060-20 Amoxicillin
0781-5060-01 Amoxicillin
0781-5061-20 Amoxicillin
0781-5061-01 Amoxicillin
0781-6039-58 Amoxicillin
0781-6039-46 Amoxicillin
0781-6039-55 Amoxicillin
0781-6156-52 Amoxicillin
0781-6156-57 Amoxicillin
0781-6156-46 Amoxicillin
0781-6041-58 Amoxicillin
0781-6041-46 Amoxicillin
0781-6041-55 Amoxicillin
0781-6157-52 Amoxicillin
0781-6157-57 Amoxicillin
0781-6157-46 Amoxicillin

Recall Number: D-1054-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
108 cartons/50 blisters per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0904-0430-95 Doxycycline Hyclate
0904-0430-04 Doxycycline Hyclate
0904-0430-06 Doxycycline Hyclate

Recall Number: D-1103-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
2 bottles/500 tablets each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

65862-187-30 Ondansetron Hydrochloride
65862-187-05 Ondansetron Hydrochloride
65862-187-99 Ondansetron Hydrochloride
65862-187-03 Ondansetron Hydrochloride
65862-187-10 Ondansetron Hydrochloride
65862-188-30 Ondansetron Hydrochloride
65862-188-05 Ondansetron Hydrochloride
65862-188-99 Ondansetron Hydrochloride
65862-188-03 Ondansetron Hydrochloride
65862-188-10 Ondansetron Hydrochloride
65862-189-11 Ondansetron Hydrochloride

Recall Number: D-1111-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/9 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

62756-520-83 Sumatriptan Succinate
62756-520-88 Sumatriptan Succinate
62756-520-08 Sumatriptan Succinate
62756-520-18 Sumatriptan Succinate
62756-520-69 Sumatriptan Succinate
62756-520-93 Sumatriptan Succinate
62756-520-01 Sumatriptan Succinate
62756-521-83 Sumatriptan Succinate
62756-521-88 Sumatriptan Succinate
62756-521-08 Sumatriptan Succinate
62756-521-18 Sumatriptan Succinate
62756-521-69 Sumatriptan Succinate
62756-521-93 Sumatriptan Succinate
62756-521-01 Sumatriptan Succinate
62756-522-83 Sumatriptan Succinate
62756-522-88 Sumatriptan Succinate
62756-522-08 Sumatriptan Succinate
62756-522-18 Sumatriptan Succinate
62756-522-69 Sumatriptan Succinate
62756-522-93 Sumatriptan Succinate
62756-522-01 Sumatriptan Succinate

Recall Number: D-0995-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
3 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.

Affected Packages Involved in this Recall

0078-0876-01 Tobradex

Recall Number: D-1104-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/10 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1082-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
110 cartons/5000 units each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label, Rx only, MFG: Baxter, NDC# 0338-0322-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0338-0322-01 Recothrom
0338-0326-01 Recothrom
0338-0330-01 Recothrom

Recall Number: D-1037-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 box/50 blister packs per box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

50268-522-11 Meclizine Hydrochloride
50268-522-15 Meclizine Hydrochloride
50268-523-11 Meclizine Hydrochloride
50268-523-15 Meclizine Hydrochloride

Recall Number: D-1088-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 box/100 blisters packs per box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0904-6351-61 Levofloxacin
0904-6352-61 Levofloxacin
0904-6353-61 Levofloxacin

Recall Number: D-1102-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
120 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

61314-631-36 Neomycin And Polymyxin B Sulfates And Dexamethasone

Recall Number: D-1059-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
32 cartons/100 blister packs per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0904-2725-61 Sulfamethoxazole And Trimethoprim

Recall Number: D-1095-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
30 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0409-1159-18 Bupivacaine Hydrochloride
0409-1159-01 Bupivacaine Hydrochloride
0409-1159-19 Bupivacaine Hydrochloride
0409-1159-02 Bupivacaine Hydrochloride
0409-1160-18 Bupivacaine Hydrochloride
0409-1160-01 Bupivacaine Hydrochloride
0409-1162-18 Bupivacaine Hydrochloride
0409-1162-01 Bupivacaine Hydrochloride
0409-1162-19 Bupivacaine Hydrochloride
0409-1162-02 Bupivacaine Hydrochloride
0409-1163-18 Bupivacaine Hydrochloride
0409-1163-01 Bupivacaine Hydrochloride
0409-1165-18 Bupivacaine Hydrochloride
0409-1165-01 Bupivacaine Hydrochloride
0409-1165-19 Bupivacaine Hydrochloride
0409-1165-02 Bupivacaine Hydrochloride
0409-9043-11 Bupivacaine Hydrochloride And Epinephrine
0409-9043-01 Bupivacaine Hydrochloride And Epinephrine
0409-9046-11 Bupivacaine Hydrochloride And Epinephrine
0409-9046-01 Bupivacaine Hydrochloride And Epinephrine
0409-9045-11 Bupivacaine Hydrochloride And Epinephrine
0409-9045-01 Bupivacaine Hydrochloride And Epinephrine
0409-9045-16 Bupivacaine Hydrochloride And Epinephrine
0409-9045-17 Bupivacaine Hydrochloride And Epinephrine
0409-9042-11 Bupivacaine Hydrochloride And Epinephrine
0409-9042-01 Bupivacaine Hydrochloride And Epinephrine
0409-9042-16 Bupivacaine Hydrochloride And Epinephrine
0409-9042-17 Bupivacaine Hydrochloride And Epinephrine

Recall Number: D-1020-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
96 pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0487-9501-25 Albuterol Sulfate
0487-9501-03 Albuterol Sulfate
0487-9501-60 Albuterol Sulfate
0487-9501-01 Albuterol Sulfate

Recall Number: D-1068-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/30 pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0591-3525-11 Lidocaine
0591-3525-30 Lidocaine

Recall Number: D-1024-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 aerosol

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0781-7296-85 Albuterol Sulfate

Recall Number: D-1097-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
177 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0009-3073-01 Depo-medrol
0009-3073-03 Depo-medrol
0009-3475-01 Depo-medrol
0009-3475-03 Depo-medrol

Recall Number: D-1094-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 bottle/100 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1112-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/10 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial, Rx only, MFG: Viatris, NDC 0049-3920-83

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0049-3960-60 Geodon
0049-3980-60 Geodon
0049-3990-60 Geodon
0049-3920-20 Geodon
0049-3920-83 Geodon
0049-3920-01 Geodon
0049-3920-10 Geodon
0049-0052-60 Geodon
0049-0054-60 Geodon
0049-0056-60 Geodon
0049-0058-60 Geodon
0049-0352-60 Geodon
0049-0354-60 Geodon
0049-0356-60 Geodon
0049-0358-60 Geodon

Recall Number: D-1085-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
16 boxes/50 pouches per box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-01 (current)

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

10361-793-01 E-z-gas Ii

Recall Number: D-1096-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
2 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0009-3073-01 Depo-medrol
0009-3073-03 Depo-medrol
0009-3475-01 Depo-medrol
0009-3475-03 Depo-medrol

Recall Number: D-1106-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
30 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0168-0003-15 Triamcinolone Acetonide
0168-0003-80 Triamcinolone Acetonide
0168-0004-15 Triamcinolone Acetonide
0168-0004-80 Triamcinolone Acetonide
0168-0004-16 Triamcinolone Acetonide
0168-0002-15 Triamcinolone Acetonide

Recall Number: D-1019-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
23 pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0487-9501-25 Albuterol Sulfate
0487-9501-03 Albuterol Sulfate
0487-9501-60 Albuterol Sulfate
0487-9501-01 Albuterol Sulfate

Recall Number: D-1045-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0168-0146-16 Hydrocortisone
0168-0146-30 Hydrocortisone
0168-0080-16 Hydrocortisone
0168-0080-31 Hydrocortisone

Recall Number: D-1052-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
76 trays/25 vials per tray

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

63323-492-04 Xylocaine Mpf
63323-492-27 Xylocaine Mpf
63323-492-09 Xylocaine Mpf
63323-492-57 Xylocaine Mpf
63323-492-07 Xylocaine Mpf
63323-492-37 Xylocaine Mpf
63323-492-03 Xylocaine Mpf
63323-492-31 Xylocaine Mpf
63323-491-01 Xylocaine Mpf
63323-491-57 Xylocaine Mpf
63323-495-09 Xylocaine Mpf
63323-495-27 Xylocaine Mpf
63323-495-04 Xylocaine Mpf
63323-495-07 Xylocaine Mpf
63323-485-01 Xylocaine
63323-485-27 Xylocaine
63323-485-03 Xylocaine
63323-485-57 Xylocaine
63323-486-01 Xylocaine
63323-486-17 Xylocaine
63323-486-02 Xylocaine
63323-486-27 Xylocaine
63323-486-05 Xylocaine
63323-486-57 Xylocaine
63323-484-57 Xylocaine
63323-489-02 Xylocaine Mpf
63323-489-27 Xylocaine Mpf
63323-489-03 Xylocaine Mpf
63323-489-21 Xylocaine Mpf
63323-489-01 Xylocaine Mpf
63323-489-17 Xylocaine Mpf
63323-488-07 Xylocaine Mpf
63323-488-37 Xylocaine Mpf
63323-488-03 Xylocaine Mpf
63323-488-31 Xylocaine Mpf
63323-488-01 Xylocaine Mpf
63323-488-17 Xylocaine Mpf
63323-481-01 Xylocaine
63323-481-57 Xylocaine
63323-483-03 Xylocaine
63323-483-27 Xylocaine
63323-483-01 Xylocaine
63323-483-57 Xylocaine
63323-482-01 Xylocaine
63323-482-17 Xylocaine
63323-482-03 Xylocaine
63323-482-27 Xylocaine
63323-482-05 Xylocaine
63323-482-57 Xylocaine
63323-487-01 Xylocaine Mpf
63323-487-17 Xylocaine Mpf
63323-487-07 Xylocaine Mpf
63323-487-37 Xylocaine Mpf
63323-487-03 Xylocaine Mpf
63323-487-31 Xylocaine Mpf

Recall Number: D-1028-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 tube

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0168-0055-15 Betamethasone Dipropionate
0168-0055-46 Betamethasone Dipropionate
0168-0056-15 Betamethasone Dipropionate
0168-0056-46 Betamethasone Dipropionate
0168-0057-60 Betamethasone Dipropionate

Recall Number: D-1047-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
23 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0168-0357-05 Lidocaine And Prilocaine
0168-0357-55 Lidocaine And Prilocaine
0168-0357-56 Lidocaine And Prilocaine
0168-0357-30 Lidocaine And Prilocaine

Recall Number: D-1049-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/4 bottles per carton/25 tablets per bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1065-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
6 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0168-0099-15 Ketoconazole
0168-0099-30 Ketoconazole
0168-0099-60 Ketoconazole

Recall Number: D-1053-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
33 trays/25 vials per tray

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

63323-492-04 Xylocaine Mpf
63323-492-27 Xylocaine Mpf
63323-492-09 Xylocaine Mpf
63323-492-57 Xylocaine Mpf
63323-492-07 Xylocaine Mpf
63323-492-37 Xylocaine Mpf
63323-492-03 Xylocaine Mpf
63323-492-31 Xylocaine Mpf
63323-491-01 Xylocaine Mpf
63323-491-57 Xylocaine Mpf
63323-495-09 Xylocaine Mpf
63323-495-27 Xylocaine Mpf
63323-495-04 Xylocaine Mpf
63323-495-07 Xylocaine Mpf
63323-485-01 Xylocaine
63323-485-27 Xylocaine
63323-485-03 Xylocaine
63323-485-57 Xylocaine
63323-486-01 Xylocaine
63323-486-17 Xylocaine
63323-486-02 Xylocaine
63323-486-27 Xylocaine
63323-486-05 Xylocaine
63323-486-57 Xylocaine
63323-484-57 Xylocaine
63323-489-02 Xylocaine Mpf
63323-489-27 Xylocaine Mpf
63323-489-03 Xylocaine Mpf
63323-489-21 Xylocaine Mpf
63323-489-01 Xylocaine Mpf
63323-489-17 Xylocaine Mpf
63323-488-07 Xylocaine Mpf
63323-488-37 Xylocaine Mpf
63323-488-03 Xylocaine Mpf
63323-488-31 Xylocaine Mpf
63323-488-01 Xylocaine Mpf
63323-488-17 Xylocaine Mpf
63323-481-01 Xylocaine
63323-481-57 Xylocaine
63323-483-03 Xylocaine
63323-483-27 Xylocaine
63323-483-01 Xylocaine
63323-483-57 Xylocaine
63323-482-01 Xylocaine
63323-482-17 Xylocaine
63323-482-03 Xylocaine
63323-482-27 Xylocaine
63323-482-05 Xylocaine
63323-482-57 Xylocaine
63323-487-01 Xylocaine Mpf
63323-487-17 Xylocaine Mpf
63323-487-07 Xylocaine Mpf
63323-487-37 Xylocaine Mpf
63323-487-03 Xylocaine Mpf
63323-487-31 Xylocaine Mpf

Recall Number: D-1084-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
19 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

32909-764-01 E-z-hd

Recall Number: D-1031-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0338-0013-06 Sterile Water
0338-0013-08 Sterile Water
0338-0013-29 Sterile Water

Recall Number: D-1018-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/30 pouches each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0487-9904-25 Albuterol Sulfate
0487-9904-01 Albuterol Sulfate
0487-9904-02 Albuterol Sulfate
0487-0301-01 Albuterol Sulfate
0487-0301-02 Albuterol Sulfate

Recall Number: D-1057-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
16 cartons/100 blisters packs per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1092-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 bottle/100 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0378-2100-01 Loperamide Hydrochloride
0378-2100-05 Loperamide Hydrochloride

Recall Number: D-1109-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1063-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
363 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-090-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1080-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
16 cartons/6 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1122-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1007-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
16 single dose vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose vials, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0173-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1036-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
8 boxes/12 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0023-15

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0065-0023-15 Miostat

Recall Number: D-1016-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
15 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1091-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
9 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

67457-218-10 Duraclon

Recall Number: D-1119-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0338-0519-58 Intralipid
0338-0519-09 Intralipid
0338-0519-13 Intralipid

Recall Number: D-1001-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
16 cartons/24 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1029-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-0996-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
24 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1121-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
4 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1077-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
31 cartons/10 & 25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1098-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
172 packs/10 per pack

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC 04094-933-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1110-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-0994-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
45 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.

Affected Packages Involved in this Recall

24208-539-20 Miochol E

Recall Number: D-1010-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 case

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1099-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
157 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1061-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
885 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1015-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
25 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1078-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
564 cartons/25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1108-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
31 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1072-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
796 cartons/1 vial each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0045-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1030-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
8 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1120-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
2 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-58

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0338-0519-58 Intralipid
0338-0519-09 Intralipid
0338-0519-13 Intralipid

Recall Number: D-1003-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 cartons/2 ml single dose vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1070-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
983 cartons/1 vial each and 107 cartons/25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1069-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
89 cartons/25 vials per carton and 3 cartons/1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1000-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
34 cartons/ 25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1006-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
18 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol Chemical Co, NDC 12870-0001-02

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1002-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
32 cartons/25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1058-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 bottle/1000 tablets per bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0536-1047-10 Sodium Bicarbonate Antacid

Recall Number: D-1113-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
43 cartons/12 blister packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0065-0741-12 Tetracaine Hydrochloride
0065-0741-14 Tetracaine Hydrochloride

Recall Number: D-1034-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
4 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0065-0795-15 Bss
0065-0795-30 Bss
0065-0795-25 Bss
0065-0795-50 Bss

Recall Number: D-1100-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
14 packs/ 5 per pack

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1079-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
20 cartons/10 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1067-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
2 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0591-2927-54 Levalbuterol Tartrate Hfa Inhalation

Recall Number: D-1005-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
2 cartons/2 single dose vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1004-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/30 patches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1066-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
63 bottles/100 count

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1087-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0270-0556-15 Kinevac

Recall Number: D-1090-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
22 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1064-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-473-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1089-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
51 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial, Rx only, MFG: Merck Company, NDC 0085-4320-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-0997-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
13 carton/10 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

55150-174-10 Azithromycin

Recall Number: D-1023-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
5 aerosols

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1073-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1088 cartons/1 vial each and 63 cartons/25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1050-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1074-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
816 cartons/1 vial each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL multi-dose vials, Rx only, MFG: Teva Pharma USA, NDC 0703-0063-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1086-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 case

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0270-0445-35 Gastrografin
0270-0445-40 Gastrografin

Recall Number: D-0999-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
4 cartons/25 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1062-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
263 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1033-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
13 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0065-0795-15 Bss
0065-0795-30 Bss
0065-0795-25 Bss
0065-0795-50 Bss

Recall Number: D-1107-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
44 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1044-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
7 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

61314-656-25 Ciprofloxacin Hydrochloride
61314-656-05 Ciprofloxacin Hydrochloride
61314-656-10 Ciprofloxacin Hydrochloride

Recall Number: D-1101-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 case/100 unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc.

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0121-0489-05 Diphenhydramine Hydrochloride
0121-0489-00 Diphenhydramine Hydrochloride
0121-0978-10 Diphenhydramine Hydrochloride
0121-0978-00 Diphenhydramine Hydrochloride

Recall Number: D-1056-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
3 boxes/100 blisters per box

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1008-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
799 cartons/1 bottle each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0065-0411-30 Betadine

Recall Number: D-1071-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
65 cartons/1 vial each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), 5 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0043-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1035-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
13 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0065-0303-55 Isopto Atropine

Recall Number: D-1060-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
780 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1039-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
4 bottles/30 tablets per bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0406-1170-03 Naltrexone Hydrochloride
0406-1170-01 Naltrexone Hydrochloride

Recall Number: D-1017-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
187 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1081-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
49 cartons/6 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

78670-003-67 Revonto

Recall Number: D-1076-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
56 inhalers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1038-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton/10 vials per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1105-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
50 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

61314-637-05 Prednisolone Acetate
61314-637-10 Prednisolone Acetate
61314-637-15 Prednisolone Acetate

Recall Number: D-1043-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
3 cartons/30 pouches per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0603-1880-10 Lidocaine
0603-1880-16 Lidocaine

Recall Number: D-1093-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
8 bottles/100 tablets each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0378-1101-01 Prazosin Hydrochloride
0378-1101-10 Prazosin Hydrochloride
0378-2302-01 Prazosin Hydrochloride
0378-2302-10 Prazosin Hydrochloride
0378-3205-01 Prazosin Hydrochloride
0378-3205-25 Prazosin Hydrochloride

Recall Number: D-1114-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
1 carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

69238-1616-6 Ofloxacin
69238-1615-3 Ofloxacin

Recall Number: D-1013-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
55 packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-102-02

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

49502-102-01 Epinephrine
49502-102-02 Epinephrine
49502-101-01 Epinephrine
49502-101-02 Epinephrine

Recall Number: D-1027-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
29 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz Pharma, NDC 0781-2321-06

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0781-2321-06 Aprepitant
0781-2321-51 Aprepitant
0781-2322-06 Aprepitant
0781-2322-68 Aprepitant
0781-2322-46 Aprepitant
0781-4063-36 Aprepitant
0781-2323-06 Aprepitant
0781-2323-68 Aprepitant

Recall Number: D-1116-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
46 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

63323-269-30 Diprivan
63323-269-50 Diprivan
63323-269-35 Diprivan
63323-269-65 Diprivan
63323-269-22 Diprivan
63323-269-29 Diprivan
63323-269-01 Diprivan
63323-269-10 Diprivan

Recall Number: D-1041-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
240 cartons/3 blister packs per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1118-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
39 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3105-11

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0264-3103-11 Cefazolin Sodium
0264-3105-11 Cefazolin Sodium
0264-3107-11 Cefazolin Sodium

Recall Number: D-0998-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
224 cartons/10 vials each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

55150-167-10 Bupivacaine Hydrochloride
55150-168-30 Bupivacaine Hydrochloride
55150-169-10 Bupivacaine Hydrochloride
55150-170-30 Bupivacaine Hydrochloride
55150-171-10 Bupivacaine Hydrochloride
55150-172-30 Bupivacaine Hydrochloride
55150-249-50 Bupivacaine Hydrochloride
55150-250-50 Bupivacaine Hydrochloride

Recall Number: D-1083-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
56 cartons/10 patches each

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 10019-553-03

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

10019-553-03 Transderm Scop
10019-553-04 Transderm Scop
10019-553-90 Transderm Scop
10019-553-06 Transderm Scop
10019-008-10 Transderm Scop
10019-008-24 Transderm Scop
10019-008-01 Transderm Scop
10019-008-04 Transderm Scop

Recall Number: D-1026-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
21 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

61314-665-05 Apraclonidine
61314-665-10 Apraclonidine

Recall Number: D-1048-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
7 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1042-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
30 cartons/3 blister packs per carton

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1040-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
57 pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

0487-9801-25 Ipratropium Bromide
0487-9801-30 Ipratropium Bromide
0487-9801-60 Ipratropium Bromide
0487-9801-01 Ipratropium Bromide
0487-9801-02 Ipratropium Bromide

Recall Number: D-1115-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
122 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

63323-269-30 Diprivan
63323-269-50 Diprivan
63323-269-35 Diprivan
63323-269-65 Diprivan
63323-269-22 Diprivan
63323-269-29 Diprivan
63323-269-01 Diprivan
63323-269-10 Diprivan

Recall Number: D-1051-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
13 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Recall Number: D-1014-2022

Reason for Recall
cGMP deviations: Temperature abuse
Initiated
04-13-2022
Reported
06-15-2022
Quantity
30 packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89646
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-30-2023
Product Description About Product Description
Full technical description of the product.
Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02

Batch or Lot Expiration Information

Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Affected Packages Involved in this Recall

49502-102-01 Epinephrine
49502-102-02 Epinephrine
49502-101-01 Epinephrine
49502-101-02 Epinephrine